A Confirmatory Study of AMG 162 (Denosumab) in Patients With Rheumatoid Arthritis on DMARDs Treatment (Phase III)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 679
- 主要终点
- Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo
研究概览
简要总结
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously to rheumatoid arthritis participants.
详细描述
To evaluate the inhibitory effect of progression, compared with placebo, in joint destruction by AMG 162 administered subcutaneously at a dose of 60 mg every 6 months or every 3 months for 12 months to rheumatoid arthritis participants.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with rheumatoid arthritis according to the American College of Rheumatology (ACR) criteria for rheumatoid arthritis classification (1987 revision) or the 2010 ACR-EULAR (The European League Against Rheumatism) classification criteria for rheumatoid arthritis
排除标准
- •Functional class IV according by the ACR revised classification (1991)
研究组 & 干预措施
Denosumab 6 months
denosumab administered subcutaneously every 6 months
干预措施: denosumab (Drug)
Denosumab 3 months
denosumab administered subcutaneously every 3 months
干预措施: denosumab (Drug)
placebo
placebo administered subcutaneously to match denosumab
干预措施: placebo (Drug)
结局指标
主要结局
Change in Total Sharp Score (TSS) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo
时间窗: baseline to month 12
Change from baseline in Total Sharp Score (TSS) from baseline to month 12 was assessed. The TSS was defined as the sum of the erosion score and the joint space narrowing scores from radiographic assessments. The maximum radiographic TSS from the both hands/wrists and both feet is 448. Higher values represented greater damage.
次要结局
- Change in Total Sharp Score (TSS) From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo(baseline to month 6)
- Percent Change in Bone Mineral Density (BMD) From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo(baseline to month 12)
- Change in Erosion Score From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo(baseline to month 6)
- Change in Joint Space Narrowing From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo(baseline to month 12)
- Change in Joint Space Narrowing From Baseline to Month 6 Following Subcutaneous Administration of Denosumab or Placebo(baseline to month 6)
- Change in Erosion Score From Baseline to Month 12 Following Subcutaneous Administration of Denosumab or Placebo(baseline to month 12)